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Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis

RecruitingPhase 3Ages 21 Years - anyAllNational University Hospital, Singapore
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In plain words

What the trial is, and whether it could suit you

Tuberculosis (TB) is a global pandemic that despite successful treatment and bacterial eradication can cause chronic ill health, such as pulmonary impairment after tuberculosis (PIAT) and cardiovascular disease (CVD). A recent Phase 2b double-blind randomised-controlled clinical trial shows that adjunctive doxycycline therapy is safe, accelerates resolution of inflammation, suppresses tissue damaging enzyme activity and decreases pulmonary cavity volume (1). We aim to determine if adjunctive doxycycline can reduce PIAT and improve cardiovascular outcomes in a fully powered Phase III trial of 8 weeks of adjunctive doxycycline alongside standard pulmonary TB (PTB) treatment. The investigators hypothesize that doxycycline inhibits tissue destruction in patients with PTB and thereby leads to improved lung function after treatment. Specific aims 1. To assess improvement in lung function as

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
The recruitment target would be 150 patients, with 75 in each arm Inclusion criteria: Patients should meet all criteria: 1. Aged 21 years and above 2. Patients receiving โ‰ค 14 days of TB treatment or about to start standard combination TB treatment 3. Confirmed pulmonary TB with positive acid-fast bacilli smear and/or positive nucleic acid amplification test (NAAT) and/or TB culture results 4. CXR demonstrating pulmonary involvement with cavity or cavities 5. Able to provide informed consent Exclusion criteria: 1. HIV co-infection 2. Previous pulmonary TB 3. Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer 4. Pregnant or breast feeding 5. Allergies to tetracyclines 6. Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity 7. Autoimmune disease and/or on systemic immunosuppressants 8. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of study drug, or planned use during the study period 9. Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung 10. Evidence of severe depression, schizophrenia or mania 11. ALT \> 3 times upper limit of normal 12. Creatinine \> 2 times upper limit of normal 13. Principal investigator assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome
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What it tests

  • Doxycycline
  • Placebo
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Where

6 sites
Hospital Queen Elizabeth I
Kota Kinabalu, Malaysia
Klinik Kesihatan Luyang
Kota Kinabalu, Malaysia
Klinik Kesihatan Menggatal
Kota Kinabalu, Malaysia
Universiti Malaysia Sabah (UMS), Borneo Medical and Health Research Centre
Kota Kinabalu, Malaysia
National University Hospital
Singapore, Singapore
TB Control Unit
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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